A Vital Drug Runs Low, Though Its Base Ingredient Is in Many Kitchens

The shortage of sodium bicarbonate solution is only the latest example of an inexpensive hospital staple’s supply dwindling to a critical level. In recent years, hundreds of generic injectable drugs have become scarce, vexing hospital administrators and government officials, who have called on the manufacturers to give better notice when they are about to run short.

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Without an abundant supply of sodium bicarbonate, some hospitals are postponing elective procedures or making difficult decisions about which patients merit the drug. At Providence Hospital in Mobile, Ala., supplies ran so low a few weeks ago that Gino Agnelly, the head pharmacist, embarked on a desperate scavenger hunt, culling vials from the 50 crash carts that were stowed around the hospital.

Mr. Agnelly said he had been getting by with a supply of about 175 vials when a patient with a heart problem suddenly needed 35 of them.

He called a meeting of doctors and administrators, and they came to a difficult conclusion: They would need to postpone the seven open-heart operations that were scheduled for the next week. One critically ill patient was sent to a hospital across town because his surgery could not be delayed, Mr. Agnelly said.

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Pfizer sent an emergency shipment a few days later, but the continuing shortage has forced Mr. Agnelly to make hard choices.

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“Does the immediate need of a patient outweigh the expected need of a patient?” he asked. “It’s a medical and ethical question that goes beyond anything I’ve had to experience before.”

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Erin Fox, a drug shortage expert at the University of Utah, said unexpected shortfalls of critical medicines had become routine. In 2014, a shortage of saline solution — salt water — sent hospitals into a similar panic. This is not even the first time that the supply of sodium bicarbonate has run out. The last shortage occurred in 2012.

“It is unbelievably frustrating,” Ms. Fox said. “It makes me so mad that we are out of these really basic lifesaving medications.”

Mr. Sullivan, of Vanderbilt, said the shortages typically occurred with cheaper, “bread-and-butter” hospital drugs, leading him to question whether manufacturers were investing enough in the production process needed to make a reliable supply.

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“The specialty, high-dollar medicines — I don’t ever seem to see them experiencing shortages with those products,” he said.

Photo

Gino Agnelly, the head pharmacist at Providence Hospital in Mobile, Ala., has had to be careful with his supply of sodium bicarbonate injections.Credit
Meggan Haller for The New York Times

The situation with sodium bicarbonate solution appears to have begun in February when Pfizer, the main supplier, announced it was in short supply, Ms. Fox said. A spike in demand then led Amphastar to run low. Now, even less-than-ideal alternatives to sodium bicarbonate, such as sodium acetate, are difficult to obtain.

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Kuldip Patel, the associate chief pharmacy officer at Duke University Hospital in North Carolina, said he had become accustomed to the juggling act required when an old standby was suddenly unavailable.

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“It’s not like we haven’t been here before,” he said.

Mr. Patel said the problem had worsened just after Pfizer went from shipping its generic injectable products from five regional warehouses to one national distribution center, part of a reorganization after its acquisition of the drugmaker Hospira.

“That’s when it all derailed,” he said.

A spokesman for Pfizer said the shortage of sodium bicarbonate was not related to the change in distribution, but was due to a manufacturing delay caused by an outside supplier. The spokesman, Thomas Biegi, said the delay had not been caused by a problem with the supplier of the raw ingredient, sodium bicarbonate, but he added that he could not divulge further details, citing confidentiality agreements.

Regardless of the reason, Mr. Patel said, drug companies should do a better job of creating contingency plans for keeping vital drugs in supply, especially during transitions.

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“In situations like this, where a major manufacturer is buying out another major manufacturer of critically needed drugs, there has to be a detailed backup plan in case things don’t go smoothly,” Mr. Patel said.

Mr. Biegi said Pfizer was working hard to fix the problem. “Pfizer has a dedicated team focused on working with suppliers to address this and have already taken several steps to expedite supply recovery of this drug,” he said.

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Andrea Fischer, a spokeswoman for the Food and Drug Administration, said companies were asked to notify the agency of problems, but “there are no requirements that firms keep emergency supplies or that they stock up prior to any changes they make.”

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She said the agency was in close contact with the companies and “exploring all possible solutions to this critical shortage, including temporary importation, to help with this shortage until it’s resolved.”

Ms. Fischer said the agency had recently made progress in preventing supply problems. In 2011, it tracked 251 new shortages, an all-time high. But by 2016, she said, there were only 23 new shortages. Currently, more than 50 drugs are classified as being in shortage on the F.D.A. website.

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“Unfortunately,” she said, “not all shortages can be prevented.”

The shortage problem has been traced to a confluence of factors, ranging from problems with suppliers of the raw ingredients to trouble at the aging facilities where many of the most inexpensive generics are made. Consolidation in the industry has also reduced the number of companies producing certain drugs, so that when one company has a problem, the other quickly runs out as well.

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Ms. Fischer said the F.D.A. gave the approval process a priority status when a company wanted to enter a market that was in short supply.

Some large hospitals, such as Duke, house so-called compounding pharmacies, which can make custom batches of generics like sodium bicarbonate. Mr. Patel said that Duke was in the process of doing just that, but that setting up the process took time. The solution must be pure and sterile because it is injected into the bloodstream.

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At Providence Hospital in Mobile, Mr. Agnelly said he was so desperate that he had done an internet search to investigate if he could safely mix his own batch with some baking soda and water. The hospital does not have a compounding pharmacy.

He discovered just one research paper, dating to 1947, when doctors did exactly that during World War II.

“This is not new technology. These are not expensive materials,” Mr. Agnelly said, adding that he quickly abandoned the idea. “It’s not what you would expect in the First World.”